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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Product Detail

Product Description VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
Recall Number Z-1648-2013
Classification Class II
Code Info Serial numbers: J46000021, J46000110 through J46000177
Product Distributed Qty Total 69 units (28 units domestically and 41 units internationally)
Reason For Recall There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.

Event Detail

Event Id 65207
Product Type Devices
Status Ongoing
Recalling Firm Ortho-Clinical Diagnostics
City Rochester
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA Nationwide including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain
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